ZXFPC0289 Isotretinoin

CAS Number: 4759-48-2

Isotretinoin

Appearance: Yellow crystalline powder

Quality Index Standard Results

Identification: Rule of USP26 Conforms
Organic volatile impurity: Rule of USP26 Conforms
Loss on drying: ≤0.5％ 0.1%
Residue on ignition: ≤0.1％ 0.03%
Heavy metals: ≤0.002% <0.002%
Limit of Tretinoin: ≤1.0% 0.3%
Assay: 98--102% 99.2%

Conclusion: The Specification conforms to the rule of USP26.

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